Natalizumab (Tysabri) for multiple sclerosis: shared care protocol
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Tysabri HIGHLAND CLINICAL GUIDELINES ON MULTIPLE SCLEROSIS
This local guideline supplements existing national evidence based guidelines on MS (NICE) and specifically seeks to help local implementation of GMS services for patients with MS in Highland. “A guide to MS for GPs and primary care teams” published by the Multiple Sclerosis Society in 2006 is an excellent guide for clinicians. The MS Professional Network is a group of health and social care professionals with a common interest in improving services for people affected by MS. Membership is free and includes regular newsletters, conferences and learning events. To join call 020 8438 0810 or go to MS Society Uk
MS is more common the further North that people live (areas of northern latitude) 100/100,000 in South UK and 250/100,000 in North UK. Average onset aged 30 years with 3 females to 1 male affected. If you move from an area with low MS prevalence before the age of 15 to an area of high MS prevalence you take on the risk of the high prevalence. There is a 3% chance of developing MS if your mother has the disease. It is thought to be an acquired auto immune disorder in genetically susceptible individuals following exposure to one or more environmental or infectious triggers. This guideline seeks to produce accurate prevalence information in Highland by improving GP computer summary coding data. Current estimates suggest 600–800 people with MS in Highland. A National MS Register has started from 01/01/2010 for people newly diagnosed with MS. At any one time 10% of MS patients have benign MS, 65% have relapsing and remitting and 75% of these relapsing and remitting patients progress to secondary progressive. Primary progressive accounts for 10–15 % of the total.
Warning – Document uncontrolled when printed
Date of Issue: August 2007
Date of Review: June 2014
Next Review: June 2016
DIAGNOSIS AND TREATMENT
Multiple Sclerosis is a chronic disease affecting the central nervous system caused by the demyelination of nerves. The diagnosis requires 2 separate sites for demyelination also separated by time, to confirm the diagnosis. The diagnosis is made by a neurologist given the long term serious nature of the condition. However, local care pathways in Highland may include the general physicians in Rural General Hospitals for local investigation and opinion. MRI scanning, Visual Evoked Response and oligoclonal bands on lumbar puncture are used to confirm the diagnosis. General Practitioners usually discuss the possibility of a diagnosis of MS with the patient but explain that final confirmation is dependant upon investigations and specialist opinion. It is important to exclude other diseases, which may mimic MS e.g. cerebral lupus, sarcoidosis and Lyme’s disease.
Diagnostic Sub Categories of MS
Relapsing remitting MS is characterised by clearly defined disease relapses with partial or full recovery, and periods between relapses characterised by a lack of disease progression. It affects around 85% of people at the outset. On average, relapses (varying from mild to severe) last for about four to six weeks and occur slightly less than once a year. At their worst, acute relapses may require hospital treatment.
Secondary progressive MS follows on from relapsing remitting MS when people experience gradually more or worsening symptoms. To confirm that someone has moved from relapsing remitting to secondary progressive MS, there has to be clear evidence of sustained deterioration for at least six months which is completely independent of the effect of relapses. Typically, 75% of people with relapsing remitting MS will have developed secondary progressive MS after 15 years.
Primary progressive MS is characterised by a slow progression of disability from the outset, without any relapses or remissions. Commonly, it is diagnosed later than relapsing remitting MS, and affects men and women equally. Problems tend to occur in one main area, and often relate to walking. The likely explanation is that the lesions are more apparent in the spinal cord than the brain, which also means that bowel, bladder and sexual function may be involved. Primary progressive MS occurs in 10% to 15% of people diagnosed with MS.
Benign MS describes people with relapsing remitting MS who have a small number of relapses, or minor ones, followed by recovery. It is only possible to make a diagnosis of benign MS once a person has experienced little or no disability for 20 years. However, you can never say that they will be free of problems since relapses may occur after many years in which MS has been inactive. It is likely that in about 10% of people with MS, the disease will follow a benign course.
Malignant MS, which is very rare, has a rapid progressive course, leading to severe disability or death within five years of onset.
Diagnostic categories should be assigned in the General Practitioner’s computer system, according to the Read Codes. However, there are no Read Codes for clinical sub categories of MS so an Extension after F20.. for multiple sclerosis is required. These will change during the evolving clinical pattern after diagnosis and should be reviewed and updated at least annually under GMS Enhanced Services. Optic neuritis is a diagnosis in its own right and may not progress to Multiple Sclerosis. The importance of diagnostic sub categories are the indications for disease modifying therapies and prevalence studies. Following an acute episode, some patients regain lost functions while others are left with residual disability after some degree of recovery, while others progressively deteriorate with no recovery of function between attacks. Relapsing and remitting may deteriorate to secondary progressive with no functional recovery between attacks. A few very unfortunate patients just progressively deteriorate after diagnosis with the primary progressive variant.
The commonest symptoms in MS are spasticity, muscle weakness, ataxia / in coordination, dysarthria, visual impairment including diplopia, bladder and bowel dysfunction, sensory impairment and pain. Other common symptoms include MS fatigue, psychiatric morbidity including depression and anxiety, cognitive difficulties etc. Prolonged exposure to heat, stress or infection may cause a pseudo relapse.
Lhermitte’s Phenomenon describes tingling in the legs associated with neck flexion. Uhthoff’s Phenomenon describes worsening with heat or exercise, e.g. hot bath. Trigeminal neuralgia may be associated with an MS plaque.
Relapses and Disease-modifying Treatment
GP and community nurses have an important role in identifying true relapse of MS for patients and their carers. Symptom patterns can be complex in a multi system disease of the nervous system and long-term continuity of care will facilitate patient reassessments. Accurate diagnosis of pseudo-relapse and true relapse remains vital for individual patients and the population of patients with MS.
MS fatigue, heat exhaustion and infection may mimic symptoms of true relapse. A true relapse can’t be confirmed or treated until infection has been excluded. Symptomless urine infection is the most common cause of pseudo-relapse. However, true relapse can be triggered by infection, prolonged exposure to heat and stress. If symptoms persist, despite treatment of infection a course of steroids may be considered to speed up recovery from the relapse.
Relapses may be treated by oral or IV steroids. The balance between side effects, benefits and an expectant policy must be considered by the General Practitioner. Courses of steroids are best limited to 3 per year and should not be started in the presence of infection. The aim is to shorten the duration of an attack and return patients to their optimum functioning. Pulsed steroids have been shown in some research to have good recovery in Optic Neuritis.
TREATMENT PATHWAY OF PATIENTS WITH POSSIBLE MS RELAPSE
Patient with confirmed MS presents to GP with either
- An acute or sub-acute deterioration of pre-existing symptoms
- Onset of new neurological symptoms compatible with MS
GP to check
- Patient history
- Physical examination
- MSSU, FBC, CRP to exclude infection (pseudo relapse)
Tysabri is indicated for single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) to the following patient groups:
Patients with high disease activity despite treatment with beta interferon and patients with rapidly evolving severe RRMS.
TEAM ROLES, INFORMATION AND SUPPORT
General Practitioner - Considers diagnosis and makes initial referral. Details past medical history and medication list for Neurologist or local Physician. Maintains and updates the electronic patient summary and prescribing record. Supervision of repeat prescriptions and whole person medical perspective of co-existing pathologies, e.g. cancer, diabetes or psychiatric problems. Gate-keeper role to secondary care admission and specialist opinions. Prescribing oral steroids for relapses.
Community Nurses - Home nursing care for patients with persisting disabilities, with particular attention to prevention of pressure sores and care of bladder and bowel functions. Often the key health professional in care plans for severe disabilities.
Social Work Department & Community Care Services - Homecare support packages are organised by the Social Care team using single shared assessment procedures. Personal care is delivered by care workers. Review procedures must ensure appropriate levels of support during a changing illness.
Occupational Therapist – Assesses the home environment, functional ability of patients and advises on aids and adaptations. The specialist OT’s run fatigue management courses and will advise on managing cognitive dysfunction.
Physiotherapist - Physiotherapy aims to maintain and where possible improve range of movement and mobility; advise on posture; advise on mobility aids including Functional Electrical Stimulation; assess and manage spasticity jointly with rehabilitation medicine. The MS Specialist Physio has 30 hours, 60% clinical in SECHP and 40% advisory/educational. The physiotherapist can also advise on appropriate exercise and its benefits as part of a healthy lifestyle.
Dietician - Important role in patients with weight loss, poor nutritional intake, swallowing problems or PEG feeding.
Speech and Language Therapist - Referral for speech and swallowing assessments.
MS Nurses – Offer education and advice to health professionals, patients and carers. Work closely with the voluntary sector. A good source of knowledge on new treatments for MS and alternative therapies suggested to patients by newspapers, the internet or word of mouth. Support newly diagnosed patients in collaboration with Consultant Neurologist. Support patients moving from the relapsing and remitting to secondary progressive illness and teach and organise disease modifying therapies. Work with Rehabilitation Consultant in supporting people with progressive disease and those with advanced disease.
Charity Sector – Carr Gomm care can provide regular respite for carers in their own homes.
The main Carer - The main carer for a patient disabled by multiple sclerosis needs identification and recording in notes for support and advice. The citizen’s advice bureau can help them with applications for welfare benefits to support their caring role. The main carer should be offered influenza immunisation at the same time as the MS patient.
Rehabilitation Consultant - Assesses patients with residual disabilities and prescribes wheelchairs, seating and environmental control equipment, as indicated. Assesses treatment interventions for spasticity and co-ordinates generic rehabilitation team.
Consultant Neurologist - Makes diagnosis following investigations. Prescribes disease modifying treatment. Provides the focal point for Managed Clinical Network, including updating clinical guidelines and planning the introduction of new treatments and techniques.
Consultant Physician in Rural General Hospital – may be initial point of referral for medical outpatients and investigations given shorter waiting times. May admit patients to medical ward of Rural General Hospital for assessment and treatment of relapses.
Community Hospitals - Have a useful role in supporting MS care including respite admission and a treatment for acute relapse such as IV methylprednisolone. The day hospital setting also provides opportunities for multi disciplinary team assessments.
Young Adult Rehab Unit Raigmore – offers short admissions for intensive therapy or symptom management with a view to treatment being continued in the community.
Specialists –General Physicians, Urologists, Continence Nurses, Ophthalmologist, Orthotists, Rehabilitation Engineering, Driving Assessment Centre and Disability Employment Advisors all have import roles in specialist care of MS patients.
Information and support
Patients and their families require careful support and information following the new diagnosis of a serious chronic disease. The range of prognostic outcomes requires careful explanation and the opportunity to ask questions and read appropriate literature. The Multiple Sclerosis Society of Great Britain plays a key role in supporting patients and professionals to this regard as well as funding research. MS Society Tel: 0131 335 4050 (Helpline Number - 0808 8008000).
The society publishes a comprehensive guide to diagnosis, treatments, symptom relief and living with MS, which can be confidently recommended to patient and professionals as reliable evidence based information.
There are local MS Society Branches in Caithness, Lochaber, Inverness and Ross-Shire. These branches support people with MS and their families. Each branch actively fundraises and offers support with different activities, complementary therapies, financial aid etc.
Caithness - 01955 609079
Ross Shire - 01463 861342
Lochaber - 01397 772297
Inverness - 07544581460
The MS Trust is a well established organisation offering education for all health professionals interested/involved in MS. Provides written support for patients and health professionals.
Tel: 01462 476700.
There are MS therapy centres in Inverness, Wick, Portree and Oban. This is a separate charity which offers Hyperbaric Oxygen Therapy. The Inverness Therapy centre is bigger and offers the following:-
Hyperbaric Oxygen Therapy
Mini-bus Transport System
Inverness: 01463 240365.
Wick Tel: 01955 604586
Portree Tel: 01478 612984
Oban Tel: 01631 566602
Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy (HBO or HBTO), also called high dose oxygen therapy (HDOT) involves breathing oxygen through a mask in a pressurised chamber, similar to a diving bell. In multiple sclerosis, treatment usually consists of an initial course of around 20 sessions, each lasting an hour, spread over one month. Follow-up treatment is then needed at less frequent intervals.
Research into hyperbaric oxygen therapy in MS has failed to find scientific evidence that it is effective. However, anecdotal reports suggest the treatment can be helpful for some people, particularly with fatigue and bladder problems. In the UK hyperbaric oxygen therapy is available through most MS Therapy Centres.
New GMS Contract for GPs and Computer Coding
General Practitioners may contract to community partnerships to deliver the enhanced service for patients with MS. This essentially requires the setting up of a disease register by means of Read Codes and conducting an annual review of patients, and on documenting an agreed management plan and multi disciplinary review if appropriate. The information gathered at annual review for the national enhanced service in Highland, requires a depression screen and visual testing.
The Escro screens on Vision & Gpass guide doctors and nurses to the relevant read codes for MS reviews. The exact requirements for the service level agreement for the enhanced service may change from year to year.
Diagnostic & Disease Phase Read Codes:
Read codes for MS management were updated in 2008 to include the sub categories of MS and the disease phase. The root code for MS (F20..) should be recorded at the initial diagnosis and given your priority to appear in the main summary list. The diagnosis can also be tagged as an active problem in Vision.
As the disease evolves into a pattern of changes the following sub categories can be recorded at annual review or as required using the following read codes:
F204 – Benign multiple sclerosis
F205 – Malignant multiple sclerosis
F206 – Primary progressive multiple sclerosis
F207 – Relapsing and remitting multiple sclerosis
F208 – Secondary progressive multiple sclerosis
Disease Management Phase Read Codes:
These have been requested to describe the level of disability for clinicians and searches. Again these are options to update annually or as required to reflect the state of the patient’s disease.
The overall point of accurate coding is to identify groups of patients who may need extra services or new drugs as they become available in the future by means of search templates.
8Cc0 – Management of multiple sclerosis in onset phase
8Cc1 – Management of multiple sclerosis in early disease phase
8Cc2 – Management of multiple sclerosis in stable disability phase
8Cc3 – Management of multiple sclerosis in progressive disability phase
8Cc4 – Management of multiple sclerosis in palliative phase
- Diagnostic Phase - The services required here are likely to include history, neurological examination, magnetic resonance imaging and a lumbar puncture. Traditionally these are all co-ordinated by a Neurologist. MRI is available at Raigmore Hospital and diagnostic lumbar puncture can be arranged at a local hospital. The diagnostic phase is linked to patients support and education and there is a clear role for the MS Specialist Nurse.
- Early Disease Management - In this phase the main issue is the management of relapses. This includes a short course of steroid therapy to speed up recovery from an acute relapse. Also there are “disease modifying treatments” including B-Interferon for attempted relapse prevention. General Practitioners are often best placed to supervise steroid therapy for an acute relapse with oral methyl prednisolone. The evidence base is in favour of high dose short courses of methyl prednisolone rather than dexamethasone or prednisolone. Occasionally a relapse is so severe that the patient is disabled to the point of requiring emergency hospital admission and at present this would usually involve the on-call Physician. B-Interferon treatment is currently supervised by Neurologists, but the indications for starting treatment and later stopping treatment are reasonably well established, so that much of this work can be delegated, particularly if it is clear that there is an agreed system in place to help provide consistency. If someone continues to relapse on DMT refer back to neurologist as Tysabri may be considered.
- Stable Disability – Many patients remain at a functional plateau of disabilities for several years.
- Progressive Disability - Unfortunately many people become disabled and the management here becomes chiefly one of symptom relief and rehabilitation. For this phase the best hospital contact is probably the Department of Rehabilitation Medicine.
- Palliative Stage – A minority of patients with multiple sclerosis become very severely disabled requiring on-going nursing care, symptom relief, nutritional support etc. Again, General Practitioners are usually in the best position to provide the medical input into on-going palliative care. The clinical decision to “label” a patient with a non malignant condition as palliative is difficult but important. The natural history of progressive certain deterioration in malignant disease makes prognosis difficult and the concept of “illness trajectories” is helpful (Illness Trajectories and Palliative Care, Scott Murray, BMJ 2005; 330:1007-11). Patient and carer understanding, treatment goals and access to “care packages” may be helped by a palliative stage agreement and coding. Patients could be identified by clinicians asking themselves “would I be surprised if my patient were to die in the next 12 months?” (Palliative Care in Chronic Illness, Scott Murray, BMJ 2005; 330: 611-612). These articles can be found on the NHS e-library website.
Palliative Care Coding
The MS palliative care code (8Cc4) should be recorded. However, in general terms, all palliative care stage patients should also be given the generic palliative care Read code ZV57C as well, whether they have cancer, cardiac failure or a progressive neurological condition.
This method will allow searching for disease sub categories and care phase in your MS patients and if you also allocate the general palliative care code you will be able to find your MS palliative care patients included in any totals of malignant or non malignant palliative care.
The MS Society has an excellent booklet MS and Palliative Care – Multiple Sclerosis Society 2006 - which is well worth reading for clinicians faced with the small number of MS patients at the palliative care stage of the illness. It covers the treatment of neuropathic pain, use of opioids and spasm and spasticity. It also has useful advice on capacity and consent, advanced directives and living wills.
What Constitutes a Multidisciplinary Meeting and Annual Review of Needs?
Patients with multiple sclerosis have a range of disability, from mild to severe and complex. Some patients may already be under regular review by the Rehabilitation Consultant and team. The MS Specialist Nurses are taken up with new diagnosis and disease modifying treatments in addition to assessing complex needs. They are unable to attend all practices in Highland or review all MS cases with limitations in time. Occupational Therapy and Physiotherapy time is insufficient to routinely review every patient annually. The primary purpose of the GP annual review is to assess and triage for these limited resources by means of reviewing patient, notes, and medication, this may or may not include the District Nurse. The documentation of this process and action points constitutes the annual review of needs.
At the annual review patients should be asked specifically about problems with their bladder or bowels. If problems are suspected or documented then referral to an appropriate clinician for a bladder scan, urine culture etc. is required. Sometimes patients will be unaware of voiding dysfunction or have an unrecognised UTI which can exacerbate their MS. OTs are physios should also be aware of possible problems both with mobility, access to the toilet, clothing etc. Especially in the early stages pelvic floor muscle training should be advised to help the muscles maintain function and may improve continence and voiding function. Referral to a continence specialist may be appropriate. Advice on adequate fluid intake and reducing caffeine intake can be beneficial. For those with frequency, urgency etc. anticholinergics may be recommended but these should be used in conjunction with monitoring as they may increase voiding dysfunction. Repeated urinary tract infections may be a sign of poor voiding and a scan is again indicated.
ISC can be used successfully in many patients with MS but often it can take a long time for the patient to accept and master the technique and should be taught by a competent health care professional.
It is important to discuss bladder issues with the patient, sometimes if they are given an explanation of why they are having problems then simple strategies can help.
Constipation can also be a major problem with some patients and may be attributable to poor diet, decreased fluid intake, lack of exercise, medications such as anticholinergics and pain relief as well as a slow transit colon etc. Again simple explanation of self help measures are helpful but referral to a continence specialist or dietician may be necessary.
Source: A UK Consensus on the Management of the Bladder in Multiple Sclerosis (Multiple Sclerosis Trust)
Some patients with MS may have a coexisting chronic or acute diagnosis such as learning disability, diabetes, psychiatric illness or malignant disease. The annual review by the General Practitioner may have to take into account the management of dual diagnosis.
Adults with Incapacity Act
At annual review of more severely affected patients, consideration should be given as to whether the patient has the capacity to consent to their routine medical and nursing treatment. If they are approaching the stage where the onset of dementia is likely, they should be encouraged to appoint Power of Attorney to deal with their affairs when required. This would usually be the next of kin or their nearest carer. It can be an expensive process, but help with the costs may be possible via either the MS or Alzheimer’s disease societies. If the doctor considers they are unable to consent to treatment, a medical certificate of incapacity should be issued to the main carer, usually accompanied by a treatment plan form.
Further information from: - https://www.gov.scot/policies/social-care/adults-with-incapacity/ - look at part 5 – medical treatment and research.
Testing of Visual Acuity
Annual testing of visual acuity has been required in enhanced service contract. However, not all patients with optic neuritis go on to develop MS and not all MS is complicated by demyelination of the optic nerve. However, deterioration of visual acuity correctable by glasses may occur in a severely disabled person and be forgotten about. Simple screening questions about ability to read newspapers, and then if necessary referral to an Optometrist, should be considered and documented annually.
Enhanced service contract requires depression screening. Mood changes and personality change in multiple sclerosis are common with demyelination affecting frontal lobes. During the initial diagnostic and uncertainty of prognosis phase of multiple sclerosis an adjustment disorder may occur which causes depressive symptoms. Both mild to moderate depression and euphoria may complicate the chronic phase of the illness. This point needs to be considered at annual review by the General Practitioner. Screening questions and depression scores may be helpful assessments.
The carers of patients with chronic disability may carry considerable burden and are often not given a formal opportunity to express their own needs and concerns with regard to the patient. Patients with mild disability may not require a carer but questions about the main carer should be considered at the annual review and their views formally sought and documented where appropriate at the annual patient review.
TREATMENT OF A RELAPSE OF MULTIPLE SCLEROSIS
Steroid therapy is given for relapse of MS symptoms, usually for symptoms which are distressing or result in a limitation of your usual activities.
Steroids are not without side effects. Generally though these do not continue for long after the treatment is completed. You may experience some of the following:
- Slight reddening or flushing of the face
- Swelling of the ankles
- Metallic taste in mouth
- Urinary tract infections, thrush, or sugar in the urine
- Mood alterations
- Altered sleep pattern
- Weight gain, increased appetite
You should also tell your doctor if you are diabetic (steroids will affect your sugar levels) or if there is a chance you may be pregnant.
If you have any further question please contact the person who has prescribed the medication or speak with your local MS nurse.
Northern NHS Highland please contact MS Specialist Nurse 01463 705879.
Argyll and Bute please contact MS Specialist Nurse 0141 232 7757.